PARADISE: Predicting AF After Cardiac Surgery

NCT05255224 | Unknown

• 1 other identifier: PID15669
• Study Type: observational
• Target: 13,684
• Locations: 1 country
• Sites: 1

Brief Summary

The PARADISE study aims to develop and validate prediction tools to identify patients at risk of Atrial Fibrillation (AF) after cardiac surgery.

Conditions

Atrial Fibrillation New Onset

Keywords

New Onset Atrial Fibrillation; Cardiac Surgery

Outcome Measures

Primary Outcomes (3)

• Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set

  Model discrimination (c-statistic) to predict Atrial Fibrillation in external data set

  Within 7 days of cardiac surgery

• Model calibration (intercept) to predict Atrial Fibrillation in external data set

  Model calibration (intercept) to predict Atrial Fibrillation in external data set

  Within 7 days of cardiac surgery

• Model calibration (slope) to predict Atrial Fibrillation in external data set

  Model calibration (slope) to predict Atrial Fibrillation in external data set

  Within 7 days of cardiac surgery

Secondary Outcomes (2)

• Additional model performance metrics to predict Atrial Fibrillation in external data set

  Within 7 days of cardiac surgery

• Candidate risk factors for inclusion in new onset atrial fibrillation prognostic models

  Within 7 days of cardiac surgery

Study Arms (2)

Retrospective

Patients admitted to Mass Brigham Hospitals for cardiac surgery from 1st January 1998 to 31st December 2020

Other: Not applicable as observational study

Prospective

Patients admitted to Barts Health, Liverpool Heart and Chest Hospital, or Oxford University Hospitals NHS Foundation Trust for cardiac surgery between 1st October 2021 to 31st July 2023

Other: Not applicable as observational study

Interventions

Not applicable as observational study OTHER

Not applicable as observational study

Prospective; Retrospective

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone cardiac surgery

You may qualify if:

• Patients 18 years or over
• Admitted to hospital for any cardiac surgery

You may not qualify if:

• Patients who have requested that their data not be used for research (e.g. NHS Opt-out)

Sponsors & Collaborators

• University of Oxford: lead
• St. Bartholomew's Hospital: collaborator
• University College, London: collaborator
• Liverpool Heart and Chest Hospital NHS Foundation Trust: collaborator
• Brigham and Women's Hospital: collaborator
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

Critical Care Research Group, Nuffield Department of Clinical Neurosciences, University of Oxford

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

Related Publications (1)

• Bedford J, Fields KG, Collins GS, Lip GYH, Clifton DA, O'Brien B, Muehlschlegel JD, Watkinson PJ, Redfern OC. Atrial fibrillation after cardiac surgery: identifying candidate predictors through a Delphi process. BMJ Open. 2024 Sep 25;14(9):e086589. doi: 10.1136/bmjopen-2024-086589.

  PMID: 39322590 DERIVED

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Peter Watkinson, MD

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Benjamin O'Brien, MD

  Deutsches Herzzentrum der Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 24, 2022
• Study Start: October 1, 2021
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: January 23, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)